NCT05728775 REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Noncardiac SurgEry
| NCT ID | NCT05728775 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Anesthesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 7,188 participants |
| Start Date | 2023-04-03 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 7,188 participants in total. It began in 2023-04-03 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this randomized controlled trial is to compare total intravenous anesthesia with remimazolam vs total intravenous anesthesia with propofol in moderate-to-high risk patients undergoing major elective noncardiac surgery under general anesthesia. The primary hypothesis is that total intravenous anesthesia with remimazolam can increase days alive and out of hospital at postoperative day 30 compared with total intravenous anesthesia with propofol.
Eligibility Criteria
Inclusion Criteria: * Age ≥45 years; * Undergoing elective major surgery under general anesthesia (expected surgery time \>2 h, expected length of postoperative stay \>2 d); * Fulfilling ≥1 of the following criteria: 1. history of coronary artery disease; 2. history of stroke; 3. history of congestive heart failure; 4. preoperative NT-proBNP \>200 pg/mL or BNP\>92 pg/mL; 5. age ≥70 years; 6. diabetes requiring medical treatment; 7. ASA status 3 or 4; 8. history of chronic kidney disease (preoperative sCr \>133 μmol/L or 1.5 mg/dL); 9. history of peripheral arterial disease; 10. preoperative serum albumin \<30 g/L; 11. preoperative hemoglobin \<100 g/L. Exclusion Criteria: * Undergoing organ transplantation, cardiac, craniocerebral, burn or interventional operations; * Low risk or minor surgery * End-stage renal disease requiring renal-replacement therapy; * Hepatic dysfunction (Child B or C); * Previous liver or kidney transplantation; * Previous allergy to general anesthetics; * Unable to receive bispectral index monitoring; * ASA score ≥5; * Exposure to general anesthesia in prior 30 days or anticipated re-exposure to general anesthesia within 30 days after surgery; * Need for prolonged airway protection or mechanical ventilatory support after surgery; * Current participation in another interventional study; * Previous participation in this study; * Pregnant or breastfeeding women.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05728775 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Anesthesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05728775 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05728775 currently recruiting?
Yes, NCT05728775 is actively recruiting participants. Contact the research team at zhaobch@mail2.sysu.edu.cn for enrollment information.
Where is the NCT05728775 trial being conducted?
This trial is being conducted at Hefei, China, Huainan, China, Suzhou, China, Beijing, China and 11 additional locations.
Who is sponsoring the NCT05728775 clinical trial?
NCT05728775 is sponsored by Nanfang Hospital, Southern Medical University. The trial plans to enroll 7,188 participants.